Study the Role of SHMT1 Polymorphism in Parkinson DiseaseNCT04706065
SHMT1 Polymorphism in Parkinson's Disease,
An observational study of Study the Role of SHMT1 Polymorphism in Parkinson Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Study the Role of SHMT1 Polymorphism in Parkinson Disease
- What is being tested?
- SHMT1 polymorphism
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2021to Jan 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient with parkinson diisease
Who may be able to join
- Patients age ≥ 50 years.
- Patients with PD diagnosed according to the United Kingdom Parkinson's Disease Society Brain Bank (UK PDS Brain Bank diagnostic criteria)
Who cannot join
- Patients with parkinsonian plus syndrome
- Patients with secondary parkinsonism
- Patients with other chronic comorbidities (renal, hepatic, and endocrinal disturbances and chronic chest disease.)
- Past and /or present history of epilepsy.
- Patients with disturbed conscious level.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Effat abdelhady tony
Asyut, 71515
Effat a tony, MD, 01097330309, effattony@aun.edu.eg
abeer a tony, MD, +201005389084, abeer_tony70@yahoo.com
About this study
Official title: Genetic Polymorphisms of Serine Hydroxylmethyl Transferase 1 (SHMT1) in Patients With Parkinson's Disease
Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases.
Read the detailed description
This case -control observational prospective study will conducted on 40 patients with PD.
- Being tested
- SHMT1 polymorphism
- Keywords
- SHMT1 polymorphism, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHMT1 polymorphismGenetic
It is to identify the role of SHMT1polymorphism in PD and examine the relationship between it and Severity of PD.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Group 1 (patients with PD) All participants will be subjected to thorough history taking, full clinical and neurological examination. Diagnosis of PD by using Brain Bank Criteria for diagnosis of Parkinson Disease , assessment of the severity of PD by using PDRS and evaluation of cognitive functions using MMSE. Receives: Genetic: SHMT1 polymorphism | |
| Group 2 | Group 2 (controls) All participants will be subjected to thorough history taking, full clinical and neurological examination. Receives: Genetic: SHMT1 polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
polymorphism of SHMT1gene
Measured: one year
Secondary outcomes (2)
the role of SHMT1plymorphism in pathogenesis PD
Measured: one year
Study the relationship of Shmt1 polymorphism to the severity of Parkinson disease
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start31 Jan 2021
- Primary completionJul 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study the Role of SHMT1 Polymorphism in Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Principal investigator, Effat AETony, MD, Assiut University
- Investigators
- Abeer a tony, MD, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706065
- Sponsor's protocol ID
- aswan
- Status last verified
- May 2021
- First submitted
- 3 Jan 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms of Serine Hydroxylmethyl Transferase 1 (SHMT1) in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04706065
- Acronym / sponsor ID
- aswan
- Keywords
- SHMT1 polymorphism, Parkinson disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases.
Detailed description
This case -control observational prospective study will conducted on 40 patients with PD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | – | Genetic: SHMT1 polymorphismGroup 1 (patients with PD) All participants will be subjected to thorough history taking, full clinical and neurological examination. Diagnosis of PD by using Brain Bank Criteria for diagnosis of Parkinson Disease , assessment of the severity of PD by using PDRS and evaluation of cognitive functions using MMSE. |
| Group 2 | – | Genetic: SHMT1 polymorphismGroup 2 (controls) All participants will be subjected to thorough history taking, full clinical and neurological examination. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient with parkinson diisease
Key inclusion criteria (2 listed)
- Patients age ≥ 50 years.
- Patients with PD diagnosed according to the United Kingdom Parkinson's Disease Society Brain Bank (UK PDS Brain Bank diagnostic criteria)
Key exclusion criteria (5 listed)
- Patients with parkinsonian plus syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHMT1 polymorphismIt is to identify the role of SHMT1polymorphism in PD and examine the relationship between it and Severity of PD. | Genetic | GROUP 1, Group 2 |
Primary outcome
polymorphism of SHMT1gene
Time frame: one year
2 secondary outcomes
the role of SHMT1plymorphism in pathogenesis PD
Time frame: one year
Study the relationship of Shmt1 polymorphism to the severity of Parkinson disease
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer a tony, MD principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study the Role of SHMT1 Polymorphism in Parkinson Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Effat a Tony, MD (+201097330309, effattony@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polymorphism of SHMT1gene (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.